The Effect of Vibration Devices on Pain and Discomfort During Local Anesthesia Administration in Children

Summary

This split-mouth randomized clinical trial will be conducted at the Department of Pediatric Dentistry, King Abdulaziz University Dental Hospital (KAAUDH). The inclusion criteria will include healthy, non-anxious, cooperative children aged six to 12 who require non-urgent dental treatment involving at least one pair of contralateral maxillary molars needing buccal infiltration anesthesia with no previous dental history or experience.

The children will be screened for eligibility, and a single trained dental intern will approach the parents or guardians of eligible children. Those who agree to be screened for participation in the study will be asked to sign an Arabic consent form. Before the scheduled screening appointment, children's anxiety levels will be assessed using a high score on the Abeer Children Dental Anxiety Scale (ACDAS) in the waiting area.

During the appointment, a single trained dental intern will perform the dental examination and prophylaxis, while two trained and calibrated dental interns will assess children's behavior using the Frankl Behavior Rating Scale.

Children found to be non-anxious based on their ACDAS score and cooperative or definitely cooperative based on the Frankl Behavior Rating Scale will be considered eligible for the study. Two treatment appointments will be scheduled for them, and consent and assent forms for participation in the study will be obtained.

Computer randomization will be performed to determine the treatment sequence (DentalVibe intraoral vibration device followed by Buzzy Bee® extraoral vibration device, or vice versa) and the site (right or left). Randomization will be performed before the first scheduled treatment appointment.

The subjects will be seated in the dental chair for five minutes to acclimate to the environment. To measure the physiological changes of the participating subjects, a pulse oximeter device (OxyWatch, ChoiceMMed, Hamburg, Germany) will be applied, and a trained dental intern will record the baseline heart rate (HR). During the treatment, HR will also be recorded.

The tip of the DentalVibe intraoral vibration device will be gently placed on the mucobuccal fold above the tooth to be anesthetized. In contrast, the Buzzy Bee® extraoral vibration device will be positioned externally above the buccal infiltration site.

During maxillary buccal infiltration, all subjects will be videotaped using a high-resolution camera, focusing on the face and body. Later, two trained and calibrated evaluators will independently assess the child's behavior during the procedure using the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Immediately after administering anesthesia, the subjects will be positioned upright, and the same trained dental intern will introduce the face version of the Visual Analogue Scale (VAS).

Finally, after completing both procedures, the subjects will be asked about their future preference for the vibration device. Due to the study's design, both the investigator administering the maxillary buccal infiltration and the subjects will not be aware of which group they belong to.

Conditions

• Children's Anxiety Levels
• Children's Behavior
• Physiological Changes (Heart Rate)
• Obejective Pain and Discomfort
• Subjective Pain and Discomfort
• Subjects' and Parents' Satisfaction
• Subjects' and Parents' Future Preference

Interventions

DEVICE

DentalVibe intraoral vibration device

DentalVibe intraoral vibration device.

DEVICE

Buzzy Bee® extraoral vibration device

Buzzy Bee® extraoral vibration device

Sponsors & Collaborators

• King Abdulaziz University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2026-04-30

Completion

2026-04-30

FDA Device

Yes

Countries

• Saudi Arabia

Study Locations